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Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia (rétroBODOM)

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ClinicalTrials.gov Identifier: NCT03363113
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
Symptoms of oromandibular dystonia can be alleviated by injections of botulinum toxin. The scope of this study is to describe the efficacy of this procedure, by a retrospective systematic review of patients medical charts

Condition or disease Intervention/treatment
Dystonia; Orofacial Drug: Botulinum Toxins

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Study Type : Observational
Actual Enrollment : 240 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Outcome of Botulinum Toxin Treatment for Oromandibular Dystonia
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 1, 2016
Actual Study Completion Date : July 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia


Intervention Details:
  • Drug: Botulinum Toxins
    Injection of botulinum toxin in the muscles affected by oromandibular dystonia


Primary Outcome Measures :
  1. Clinical improvement score [ Time Frame: Two months ]
    Likert scale for the assessment of the clinical improvement after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by botulinum toxin injection for oromandibular dystonia in the Fondation Rothschild (Paris)
Criteria

Inclusion Criteria:

  • Patient suffering from oromandibular dystonia
  • Medical follow up in the Fondation Ophtalmologique Rothschild (Paris)
  • Treatment by at least one session of botulinum toxin injection

Exclusion Criteria:

  • Patient cannot assess symptoms improvement using a Likert scale

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03363113     History of Changes
Other Study ID Numbers: CE_20150630_7_LSM
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs